CN107432895B - External plaster for eliminating dampness and relieving pain - Google Patents

External plaster for eliminating dampness and relieving pain Download PDF

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Publication number
CN107432895B
CN107432895B CN201710708928.9A CN201710708928A CN107432895B CN 107432895 B CN107432895 B CN 107432895B CN 201710708928 A CN201710708928 A CN 201710708928A CN 107432895 B CN107432895 B CN 107432895B
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rubber
parts
plaster
relieving pain
eliminating dampness
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CN107432895A (en
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俞帮和
徐�明
蒋志刚
汪海涛
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Hangzhou Rende Pharmaceutical Co ltd
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Hangzhou Rende Pharmaceutical Co ltd
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    • A61K9/7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7076Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising ingredients of undetermined constitution or reaction products thereof, e.g. rosin or other plant resins

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Abstract

The invention belongs to the technical field of plaster preparations, and particularly relates to an external plaster for eliminating dampness and relieving pain, which is prepared from musk, camphor, a slow release agent, a hot pepper fluid extract, belladonna fluid extract, methyl salicylate, diphenhydramine hydrochloride, zinc oxide, vaseline, rosin, lanolin, a transdermal enhancer, a tackifier, an emulsion enhancer and rubber, wherein the slow release agent is one of nano coconut shell activated carbon, silane coupling agent modified silicon micropowder or ethyl cellulose. The external plaster for eliminating dampness and relieving pain has very obvious effect of eliminating dampness and relieving pain, good transdermal absorption rate and quick response, the effective components in the plaster are not easy to volatilize, the plaster has good viscosity and uniform quality, and the components of the external plaster are easier to be absorbed by skin by preparing emulsified slurry and then coating adhesive in the preparation process.

Description

External plaster for eliminating dampness and relieving pain
Technical Field
The invention belongs to the technical field of plaster preparations, and particularly relates to an external plaster for eliminating dampness and relieving pain.
Background
The application history of the plaster in China is long, vegetable oil or animal oil is added with medicine and decocted into colloidal substances, the colloidal substances are coated on one surface of cloth, paper or skin and can be pasted on an affected part for a long time, the medicine in the plaster is directly pasted on body surface acupuncture points, the medicine property permeates into subcutaneous tissues from the outside to the inside through the skin and hair, on one hand, the relative advantage of the medicine concentration is generated locally, on the other hand, the medicine can directly reach the focus of viscera loss of regulating menstruation and qi imbalance through the through running of meridians and collaterals, the functional effect of the medicine is exerted, and therefore the maximum whole body pharmacological effect is exerted. The traditional injection and oral therapy damages tissues such as nerves, blood vessels, muscles and the like, so that patients are not easy to accept, and the methods can easily lead the medicine to be dispersed at various positions through the whole blood circulation, so that the medicine really reaches the local part of the disease, has small dosage but poor curative effect, avoids the toxic and side effect of oral administration, simultaneously leads the medicine to directly act on the affected part, has high medicine effect, obvious effect and difficult generation of medicine resistance, and has good effect on rheumatalgia, joint sprain and the like.
However, the existing plaster has the following production or use problems: one plaster has poor pertinence, and one plaster is used for treating various diseases, so the drug effect is not ideal; secondly, the plaster has low transdermal absorption rate, slow effect and long medication period; secondly, the effective components in the plaster are easy to volatilize, so that the drug effect is reduced; thirdly, the plaster is thin and has poor cohesiveness, and plaster covers such as release paper have poor packaging effect and are easy to be affected with damp; fourthly, the plaster quality is different due to uneven dispersion of all ingredients in the plaster; fifthly, the plaster has poor air permeability.
Chinese patent 2017100483299, entitled plaster decocted with Chinese herbal medicines and its preparation method, application date 2017, 1 month 21, discloses a plaster prepared from radix Morindae officinalis, rhizoma Dioscoreae, fructus Corni, herba cistanches, cortex Cinnamomi, radix Aconiti lateralis Preparata, radix Dipsaci, radix Glycyrrhizae, radix Achyranthis bidentatae, Scolopendra, Scorpio, radix Paeoniae alba, rhizoma Cibotii, Poria, rhizoma Atractylodis Macrocephalae, herba Lycopodii, herba speranskiae tuberculatae, herba Ephedrae, ramulus Cinnamomi, radix Notoginseng, radix Aconiti Kusnezoffii, radix Aconiti, herba asari, radix Cynanchi Paniculati, herba Stauntoniae, flos Carthami, Olibanum, Eupolyphaga Seu Steleophaga, fructus Gardeniae, radix Clematidis, radix Et rhizoma Rhei, radix Paeoniae Rubra, caulis Sargentodoxae, Borneolum Syntheticum, oleum Sesami, Colophonium, cedar, herba plantaginis, HESHANGTOU, radix Granati, sea moss, semen Strychni, rhizoma arisaematis, rhizoma Pinelliae, cortex Acanthopancis, cortex Cinnamomi, rhizoma Chuanxiong, herba asari, rhizoma Zingiberis, herba Setariae, radix rehmanniae, radix scrophulariae, ramulus Mori, radix Angelicae Dahuricae, radix Paeoniae, the plaster has the disadvantages of poor pertinence and unsatisfactory drug effect.
Disclosure of Invention
Aiming at the problems of poor pertinence and non-ideal drug effect of part of plasters, the invention aims to provide the external plaster for eliminating dampness and relieving pain, which has very obvious effect of eliminating dampness and relieving pain, good transdermal absorption rate, quick response, difficult volatilization of effective components in the plaster, good plaster viscosity and uniform quality.
The invention also aims to provide a preparation method of the external plaster for eliminating dampness and relieving pain.
The invention provides the following technical scheme:
the externally applied plaster for eliminating dampness and relieving pain is prepared from the following components in parts by weight: 5-20 parts of musk, 2000-3000 parts of camphor, 500-750 parts of sustained release agent, 1500-2250 parts of pepper fluid extract, 600-900 parts of belladonna fluid extract, 800-1200 parts of methyl salicylate, 130-185 parts of diphenhydramine hydrochloride, 7600-10400 parts of zinc oxide, 2400-3600 parts of vaseline, 6400-9600 parts of rosin, 800-1200 parts of lanolin, 200-300 parts of transdermal enhancer, 160-240 parts of tackifier, 100-200 parts of emulsion enhancer and 6800-10200 parts of rubber.
In the external plaster for eliminating dampness and relieving pain, the hot pepper fluid extract has the functions of expanding capillary vessels, improving local blood circulation and accelerating the metabolism of pain-causing substances, thereby playing the role of diminishing inflammation and relieving pain, and the pain relieving effect is good after the belladonna fluid extract is strengthened. Musk can break blood and dissolve stasis, camphor can relieve pain and itching, methyl salicylate can promote local blood circulation, zinc oxide can play a role of a filler, and reacts with rosin to generate octyl salt of abietic acid, so that emulsification of rubber is promoted. Lanolin acts to soften the rubber and to increase the viscosity. The rosin and camphor have the functions of cooling, relieving itching, reducing swelling, relieving pain, sterilizing and inhibiting bacteria by providing aromatic odor. The transdermal absorption enhancer can improve the transdermal absorption rate and transdermal speed of each component, shorten the drug effect period of the external plaster and improve the drug component utilization rate. The emulsion-increasing agent and the tackifier enhance the viscosity of the plaster, make the medicine quality of the external plaster uniform and make the emulsified nano-scale external plaster easier to be absorbed by the skin. Therefore, the external plaster has obvious effects of eliminating dampness and relieving pain, good viscosity, good transdermal absorption effect and drug effect block.
As an improvement of the invention, the slow release agent is nano coconut shell activated carbon or ethyl cellulose. The volatilization of components such as camphor and the like is reduced by increasing or decreasing the slow release agent and utilizing the porous structure of the nano coconut shell activated carbon and the silicon micropowder modified by the silane coupling agent or the skeleton tissue effect of ethyl cellulose, so that the duration of the drug effect is prolonged.
As an improvement of the invention, the transdermal enhancer comprises a main agent and an auxiliary agent, wherein the main agent is the combination of N, N-dimethylamino-isopropyl dodecyl ester and any one of ferulic acid, alpha-bisabolol and glycerol monohexyl ether, and the auxiliary agent is cocamidopropyl betaine or trioctylmethylammonium chloride. The medicine penetrates through the skin to enter the body, and the stratum corneum of the skin is a multi-layer lipid molecular layer formed by lipid-like molecules, has a compact structure and is a main barrier for transdermal absorption of the medicine. Transdermal absorption of the drug involves detachment from the patch and diffusion to the skin or mucosal surface, followed by passage through the epidermis into the dermis, the subcutaneous tissue, and through blood or lymphatic vessels into the target site. Therefore, the skin penetration rate of the medicine can be improved by the lipophilic molecules entering the horny layer and destroying the ordered close arrangement of the horny layer, and the N, N-dimethylamino dodecyl isopropoxide has good lipophilicity and can obviously improve the capability of the medicine for penetrating the horny layer. Meanwhile, the N, N-dimethylamino dodecyl isopropoxide is compounded with hydrophilic ferulic acid, alpha-bisabolol or glycerol monohexyl ether for use, so that the connection capacity of the transdermal absorption enhancer between the cuticle and the hydrophilic medicament is enhanced. The cocamidopropyl betaine or trioctylmethylammonium chloride has good surface activity, strong hydrophilic and lipophilic abilities, and can enhance the absorption promoting effect of the main agent.
As an improvement of the invention, the tackifier is nano silicon dioxide aerogel. The nano silicon dioxide aerogel has higher viscosity and good emulsifying effect, and can improve the bonding capability of the external plaster and strengthen the effect of emulsion. Meanwhile, the nano-silica aerogel has rich porosity, and forms a cross-linked network in the external plaster after high-speed homogeneous distribution, so that the air permeability of the external plaster is enhanced.
As an improvement of the invention, the emulsion enhancer is phosphatidylserine or glycerophosphate. Improves the emulsifying property of the mucilage, has good hydrophilic and lipophilic abilities simultaneously with the phosphatidylserine and the glycerophosphate, and can strengthen the absorption promoting ability of the transdermal enhancer.
A preparation method of an external plaster for eliminating dampness and relieving pain comprises the following steps:
(1) preparing glue: cutting rubber into rubber strips of 10-20 cm, putting the rubber strips into a rubber mixing mill, rolling the rubber strips to obtain rubber sheets with the thickness of 0.6-1.5 mm, and then putting the rubber sheets into a stirrer, adding a gasoline solvent, and soaking and swelling the rubber sheets;
(2) preparing materials: adding camphor and a slow-release agent into ethanol in sequence, stirring uniformly, standing for 24-48 hours at 20-27 ℃, then adding musk, methyl salicylate, rosin and diphenhydramine hydrochloride into ethanol in sequence, stirring uniformly for dissolving, then adding a transdermal enhancer, zinc oxide, vaseline, a hot pepper fluid extract and a belladonna fluid extract in sequence, stirring uniformly to obtain a mixed feed liquid, and stirring and dissolving lanolin in diethyl ether to obtain a diethyl ether feed liquid;
(3) pulping: cutting the swelled rubber slice into rubber sections with the length less than 1cm, putting the rubber sections into a rubber beating machine, adding the mixed feed liquid and the ether feed liquid, stirring and beating the rubber, sieving the rubber by a screen to obtain rubber cement, and returning the feed liquid intercepted by the screen to beating the rubber again;
(4) homogenizing: adding a tackifier and an emulsion-increasing agent into the rubber cement, uniformly stirring, and then feeding the rubber cement into a high-speed homogenizer to perform homogenization treatment at a rotation speed of 8000-10000 r/min to obtain emulsified slurry;
(5) gluing: feeding the backing into two rolling cylinders of a glue spreader, adding emulsified slurry into the glue spreader, and coating the emulsified slurry on the backing to prepare paste;
(6) reel: the heating reeling machine controls the temperature of each oven in the reeling machine to be respectively: the temperature of the first oven is 55-65 ℃, the temperature of the second oven is 85-95 ℃, the temperature of the third oven is 65-75 ℃, and the paste reel is processed;
(7) pasting paper: pasting a piece of release paper on the plaster surface of the plaster, and coating a volatilization prevention layer on the outer side of the release paper;
(8) packaging: slicing according to the specified size, bagging and packaging to obtain the external plaster for eliminating dampness and relieving pain.
The components are mixed and added into the swelled rubber sheet to be rubberized to prepare the mucilage, then the mucilage is prepared by high-speed homogenization, the mixture is rubberized to be molded, and the volatilization prevention layer is coated on the outer side of the release paper to prepare the external plaster for expelling rheumatism, so that the external plaster has very obvious effects of relieving rheumatism pain and curing. After the emulsion is added, the high-speed homogenized emulsified slurry has small particle size even reaching the nanometer level, on one hand, the viscosity of the plaster is enhanced, on the other hand, the medicine quality of the external plaster is uniform, and simultaneously, the emulsified nanometer external plaster is easier to be absorbed by the skin, and the effect of the transdermal enhancer for enhancing the transdermal rate is enhanced.
As an improvement of the method, in the step (1), the mass ratio of the rubber sheet to the gasoline solvent is 1: 5.3-10.7, the gasoline solvent is formed by mixing No. 120 gasoline and ethanol, and the volume percentage of the No. 120 gasoline is 75-95%. The No. 120 gasoline has good rubber swelling effect, and can accelerate the full mixing of the gasoline solvent, the ethanol mixed solution and the ether mixed solution after being mixed with ethanol, and strengthen the uniform mixing of all ingredients and the swollen rubber.
As an improvement of the method, in the step (2), the volume ratio of the ethanol to the belladonna fluid extract is 20-36: 1, and the volume ratio of the ether to the lanolin is 4-11: 1. Sufficient ethanol and ether are provided to fully dissolve each medicine component.
As one of the methods, the backing is prepared by blending bamboo fibers, polypropylene fibers and polyacrylonitrile-based carbon fibers, and the mass ratio of the bamboo fibers to the polypropylene fibers to the polyacrylonitrile-based carbon fibers is 1.2-1.5: 0.6-0.9: 0.1-0.4. The bamboo fiber has good air permeability, can enhance the air permeability of the external plaster, and has the effects of sterilization and bacteriostasis. The polyacrylonitrile-based carbon fiber has high biocompatibility, small specific gravity, high strength, difficult deformation and difficult moisture.
As an improvement of the method of the invention, the volatilization prevention layer in the step (7) is formed by mixing and spraying the following components in parts by weight: 10-18 parts of water-soluble chitosan, 2-6 parts of hydroxypropyl methyl cellulose, 7-11 parts of alpha-cyclodextrin, 40-50 parts of ethanol and 100-120 parts of water, wherein the thickness of the layer is 1-5 mu m. By coating the surface of the release paper with a volatilization prevention layer, volatile components are prevented from volatilizing, and moisture and humidity are prevented. The water-soluble chitosan has an antibacterial effect and acts together with the guar gum ether to form a film layer, and the alpha-cyclodextrin has a cage structure, so that the volatilization of components can be effectively prevented, and the effect of prolonging the drug effect is achieved.
The invention has the following beneficial effects:
the external plaster for eliminating dampness and relieving pain has very obvious effect of eliminating dampness and relieving pain, good transdermal absorption rate, quick response, difficult volatilization of effective components in the plaster, good plaster viscosity and uniform quality. Meanwhile, in the preparation process, the emulsified slurry is prepared firstly and then the adhesive is coated, so that the components of the external plaster are easier to be absorbed by the skin.
Detailed Description
The following further describes the embodiments of the present invention.
The starting materials used in the present invention are commercially available or commonly used in the art, unless otherwise specified, and the methods in the following examples are conventional in the art, unless otherwise specified.
Example 1
An external plaster for eliminating dampness and relieving pain is prepared from the following components: 5g of musk, 2000g of camphor, 5000g of sustained release agent, 1500g of hot pepper fluid extract, 600g of belladonna fluid extract, 800g of methyl salicylate, 130g of diphenhydramine hydrochloride, 7600g of zinc oxide, 2400g of vaseline, 6400g of rosin, 800g of lanolin, 200g of transdermal enhancer, 160g of tackifier, 100g of emulsion enhancer and 6800g of rubber.
The sustained release agent is preferably nano coconut shell activated carbon, the transdermal enhancer comprises a main agent and an auxiliary agent, the mass percentage of the main agent is 55%, the main agent is a combination of N, N-dimethylamino dodecyl isopropoxide and ferulic acid, the mass ratio of the N, N-dimethylamino dodecyl isopropoxide to the ferulic acid is 1:0.3, the auxiliary agent is cocamidopropyl betaine, the tackifier is preferably nano silicon dioxide aerogel, and the emulsifying agent is preferably phosphatidylserine.
A preparation method of an external plaster for eliminating dampness and relieving pain comprises the following steps:
(1) preparing glue: removing a film from rubber, cutting the rubber into rubber strips with the length of 10cm, putting the rubber strips into a rubber mixing mill for rolling to obtain rubber sheets with the thickness of 0.6mm, adding a gasoline solvent with the mass 5.3 times of that of the rubber sheets into a stirrer, soaking at 10 ℃ to fully swell and soften the rubber sheets, wherein the soaking time is not less than 24 hours, preferably 24 hours, the gasoline solvent is preferably prepared by mixing No. 120 gasoline and ethanol, and the volume percentage of the No. 120 gasoline is 75%;
(2) preparing materials: adding camphor and a slow-release agent into ethanol in sequence, stirring uniformly, standing for 24 hours at 20 ℃, then adding musk, methyl salicylate, rosin and diphenhydramine hydrochloride into ethanol in sequence, stirring uniformly for dissolving, then adding a transdermal enhancer, zinc oxide, vaseline, a pepper fluid extract and a belladonna fluid extract in sequence, stirring uniformly to obtain a mixed feed liquid, wherein the volume of ethanol is 20 times that of the belladonna fluid extract, and stirring and dissolving lanolin in diethyl ether with the volume of 4 times that of the belladonna fluid extract to obtain a diethyl ether feed liquid;
(3) pulping: cutting the swelled rubber slice into rubber sections with the length less than 1cm, putting the rubber sections into a rubber beating machine, adding the mixed feed liquid and the ether feed liquid, stirring and beating the rubber, sieving the rubber by a screen to obtain rubber cement, and returning the feed liquid intercepted by the screen to beating the rubber again;
(4) homogenizing: adding a tackifier and an emulsion-increasing agent into the rubber cement, uniformly stirring, and then feeding the rubber cement into a high-speed homogenizer for homogenizing treatment at a rotation speed of 8000r/min to obtain emulsified slurry;
(5) gluing: feeding the backing into two rolling cylinders of a glue spreader, adding emulsified slurry into the glue spreader, and coating the emulsified slurry on the backing to prepare paste, wherein the backing is prepared by blending bamboo fibers, polypropylene fibers and polyacrylonitrile-based carbon fibers, and the mass ratio of the bamboo fibers to the polypropylene fibers to the polyacrylonitrile-based carbon fibers is 1.2:0.6: 0.1;
(6) reel: the heating reeling machine controls the temperature of each oven in the reeling machine to be respectively: the temperature of the first oven is 55 ℃, the temperature of the second oven is 85 ℃, the temperature of the third oven is 65 ℃, the paste reel is processed, each reel is cut off once in a length of 100m, and a small sample is cut off after the reel starts for 5min to test the paste content;
(7) pasting paper: the plaster surface of the plaster is adhered with a piece of stripping paper, the outer side of the stripping paper is coated with a volatilization prevention layer with the thickness of 1 mu m, and the volatilization prevention layer is formed by mixing and spraying the following components: 10g of water-soluble chitosan, 2g of hydroxypropyl methyl cellulose, 7g of alpha-cyclodextrin, 40g of ethanol and 100g of water;
(8) packaging: slicing according to the specified size, bagging and packaging to obtain the external plaster for eliminating dampness and relieving pain.
Example 2
An external plaster for eliminating dampness and relieving pain is prepared from the following components: 12.5g of musk, 2500g of camphor, 625g of sustained release agent, 1875g of capsicum fluid extract, 750g of belladonna fluid extract, 1000g of methyl salicylate, 157.5g of diphenhydramine hydrochloride, 9000g of zinc oxide, 3000g of vaseline, 8000g of rosin, 1000g of lanolin, 250g of transdermal enhancer, 200g of tackifier, 150g of emulsion enhancer and 8500g of rubber.
The sustained-release agent is preferably nano coconut shell activated carbon, the transdermal enhancer comprises a main agent and an auxiliary agent, the mass percentage of the main agent is 70%, the main agent is a combination of N, N-dimethylamino dodecyl isopropoxide and alpha-bisabolol, the mass ratio of the N, N-dimethylamino dodecyl isopropoxide to the alpha-bisabolol is 1:0.7, the auxiliary agent is trioctyl methyl ammonium chloride, the tackifier is preferably nano silicon dioxide aerogel, and the emulsion enhancer is preferably glycerophosphate.
A preparation method of an external plaster for eliminating dampness and relieving pain comprises the following steps:
(1) preparing glue: removing a film from rubber, cutting the rubber into rubber strips with the length of 15cm, putting the rubber strips into a rubber mixing mill, rolling the rubber strips to obtain rubber sheets with the thickness of 1.2mm, adding a gasoline solvent with the mass 8 times that of the rubber sheets into a stirrer, soaking the rubber sheets at 15 ℃ to fully swell and soften the rubber sheets, wherein the soaking time is not less than 24 hours, preferably 36 hours, the gasoline solvent is preferably prepared by mixing No. 120 gasoline and ethanol, and the volume percentage of the No. 120 gasoline is 85%;
(2) preparing materials: adding camphor and a slow-release agent into ethanol in sequence, stirring uniformly, standing for 36 hours at 23 ℃, then adding musk, methyl salicylate, rosin and diphenhydramine hydrochloride into ethanol in sequence, stirring uniformly for dissolving, then adding a transdermal enhancer, zinc oxide, vaseline, a pepper fluid extract and a belladonna fluid extract in sequence, stirring uniformly to obtain a mixed feed liquid, wherein the volume of ethanol is 28 times that of the belladonna fluid extract, and stirring and dissolving lanolin in 7.5 times of diethyl ether to obtain a diethyl ether feed liquid;
(3) pulping: cutting the swelled rubber slice into rubber sections with the length less than 1cm, putting the rubber sections into a rubber beating machine, adding the mixed feed liquid and the ether feed liquid, stirring and beating the rubber, sieving the rubber by a screen to obtain rubber cement, and returning the feed liquid intercepted by the screen to beating the rubber again;
(4) homogenizing: adding a tackifier and an emulsion-increasing agent into the rubber cement, uniformly stirring, and then feeding the rubber cement into a high-speed homogenizer to perform homogenization treatment at a rotation speed of 9000r/min to obtain emulsified slurry;
(5) gluing: feeding the backing into two rolling cylinders of a glue spreader, adding emulsified slurry into the glue spreader, and coating the emulsified slurry on the backing to prepare paste, wherein the backing is prepared by blending bamboo fibers, polypropylene fibers and polyacrylonitrile-based carbon fibers, and the mass ratio of the bamboo fibers to the polypropylene fibers to the polyacrylonitrile-based carbon fibers is 1.4:0.8: 0.3;
(6) reel: the heating reeling machine controls the temperature of each oven in the reeling machine to be respectively: the temperature of the first oven is 60 ℃, the temperature of the second oven is 80 ℃, the temperature of the third oven is 70 ℃, the paste reel is processed, each reel is cut off once in a length of 100m, and a sample is cut off after the reel starts for 5min to test the paste content;
(7) pasting paper: the plaster surface of the plaster is adhered with a piece of stripping paper, the outer side of the stripping paper is coated with a volatilization prevention layer with the thickness of 3 mu m, and the volatilization prevention layer is formed by mixing and spraying the following components: 14g of water-soluble chitosan, 4g of hydroxypropyl methyl cellulose, 9g of alpha-cyclodextrin, 45g of ethanol and 110g of water;
(8) packaging: slicing according to the specified size, bagging and packaging to obtain the external plaster for eliminating dampness and relieving pain.
Example 3
An external plaster for eliminating dampness and relieving pain is prepared from the following components: 20g of musk, 3000g of camphor, 750g of sustained release agent, 2250g of hot pepper fluid extract, 900g of belladonna fluid extract, 1200g of methyl salicylate, 185g of diphenhydramine hydrochloride, 10400g of zinc oxide, 3600g of vaseline, 9600g of rosin, 1200g of lanolin, 300g of transdermal enhancer, 240g of tackifier, 200g of emulsion enhancer and 10200 of rubber.
The sustained release agent is preferably ethyl cellulose, the transdermal enhancer comprises a main agent and an auxiliary agent, the mass percentage of the main agent is 85%, the main agent is N, N-dimethylamino dodecyl isopropoxide and glycerol monohexyl ether, the mass ratio of the N, N-dimethylamino dodecyl isopropoxide to the glycerol monohexyl ether is 1:1.3, the auxiliary agent is cocamidopropyl betaine, the tackifier is preferably nano silicon dioxide aerogel, and the thickening agent is preferably phosphatidylserine.
A preparation method of an external plaster for eliminating dampness and relieving pain comprises the following steps:
(1) preparing glue: removing a film from rubber, cutting the rubber into rubber strips with the length of 20cm, putting the rubber strips into a rubber mixing mill, rolling the rubber strips to obtain rubber sheets with the thickness of 1.5mm, putting the rubber sheets into a stirrer, adding a gasoline solvent with the mass of 10.7 times of that of the rubber sheets, soaking the rubber sheets at 20 ℃ to fully swell and soften the rubber sheets, wherein the soaking time is not less than 24 hours, preferably 48 hours, the gasoline solvent is preferably prepared by mixing No. 120 gasoline and ethanol, and the volume percentage of the No. 120 gasoline is 95%;
(2) preparing materials: adding camphor and a slow-release agent into ethanol in sequence, stirring uniformly, standing for 48 hours at the temperature of 27 ℃, then adding musk, methyl salicylate, rosin and diphenhydramine hydrochloride into the ethanol in sequence, stirring uniformly for dissolving, then adding a transdermal enhancer, zinc oxide, vaseline, a hot pepper fluid extract and a belladonna fluid extract in sequence, stirring uniformly to obtain a mixed feed liquid, wherein the volume of the ethanol is 36 times that of the belladonna fluid extract, and stirring and dissolving lanolin in 11 times of diethyl ether in volume to obtain a diethyl ether feed liquid;
(3) pulping: cutting the swelled rubber slice into rubber sections with the length less than 1cm, putting the rubber sections into a rubber beating machine, adding the mixed feed liquid and the ether feed liquid, stirring and beating the rubber, sieving the rubber by a screen to obtain rubber cement, and returning the feed liquid intercepted by the screen to beating the rubber again;
(4) homogenizing: adding a tackifier and an emulsion increasing agent into the rubber cement, uniformly stirring, and then feeding the rubber cement into a high-speed homogenizer to perform homogenization treatment at a rotation speed of 10000r/min to obtain emulsified slurry;
(5) gluing: feeding the backing into two rolling cylinders of a glue spreader, adding emulsified slurry into the glue spreader, and coating the emulsified slurry on the backing to prepare paste, wherein the backing is prepared by blending bamboo fibers, polypropylene fibers and polyacrylonitrile-based carbon fibers, and the mass ratio of the bamboo fibers to the polypropylene fibers to the polyacrylonitrile-based carbon fibers is 1.5:0.9: 0.4;
(6) reel: the heating reeling machine controls the temperature of each oven in the reeling machine to be respectively: the temperature of the first oven is 65 ℃, the temperature of the second oven is 85 ℃, the temperature of the third oven is 75 ℃, the paste reel is processed, each reel is cut off once in a length of 100m, and a sample is cut off after the reel starts for 5min to test the paste content;
(7) pasting paper: the plaster surface of the plaster is adhered with a piece of stripping paper, the outer side of the stripping paper is coated with a volatilization prevention layer with the thickness of 5 mu m, and the volatilization prevention layer is formed by mixing and spraying the following components: 18g of water-soluble chitosan, 6g of hydroxypropyl methyl cellulose, 11g of alpha-cyclodextrin, 50g of ethanol and 120g of water;
(8) packaging: slicing according to the specified size, bagging and packaging to obtain the external plaster for eliminating dampness and relieving pain.
In vitro transdermal test
The external plaster is tested by taking a component of muscone contained in musk as a test component, wherein the muscone has the functions of relieving swelling and pain, and the specific test conditions are as follows:
the volume is 60mL, and the effective area is 4.2cm230% ethanol physiological saline is added into a self-made Franz diffusion pool as a receiving medium, the temperature is kept to be 37.0 +/-0.1 ℃, the excised skin is fixed on the diffusion pool, one side of the corium layer of the excised skin is contacted with the receiving medium, the external plaster is attached to the side of the cuticle layer of the excised skin, and the area of the plaster side of the external plaster is 3.0cm2Setting the stirring speed to 600r/min, taking out 2mL of receiving medium after 1h, 2h, 4h, 6h, 8h, 12h and 24h respectively, immediately supplementing new 30% ethanol physiological saline with the same volume, testing the content of the musk ketone, and calculating the cumulative transmittance L.
Figure BDA0001382199450000081
Wherein L isnCumulative transmittance%, CnThe sample concentration at the nth sampling time point is [ mu ] g/mL, V is the volume of the receiving cell, CiThe sample concentration at the ith sampling time point is μ g/mL, V0Represents the sampling volume, and W represents the content mg of muscone in the external plaster. The test results of the patches for external use obtained in examples 1 to 3 are shown in Table 1.
Figure BDA0001382199450000082

Claims (5)

1. The external plaster for eliminating dampness and relieving pain is characterized by being prepared from the following components in parts by weight: 5-20 parts of musk, 2000-3000 parts of camphor, 500-750 parts of sustained release agent, 1500-2250 parts of pepper fluid extract, 600-900 parts of belladonna fluid extract, 800-1200 parts of methyl salicylate, 130-185 parts of diphenhydramine hydrochloride, 7600-10400 parts of zinc oxide, 2400-3600 parts of vaseline, 6400-9600 parts of rosin, 800-1200 parts of lanolin, 200-300 parts of transdermal enhancer, 160-240 parts of tackifier, 100-200 parts of emulsion enhancer and 6800-10200 parts of rubber;
the transdermal enhancer comprises a main agent and an auxiliary agent, wherein the main agent is a composition of N, N-dimethylamino-isopropyl dodecyl ester and ferulic acid according to the mass ratio of 1:0.3, the mass percentage of the main agent is 55%, and the auxiliary agent is cocamidopropyl betaine;
the slow release agent is ethyl cellulose;
the tackifier is nano silicon dioxide aerogel;
the emulsion increasing agent is phosphatidylserine;
the preparation method of the external plaster for eliminating dampness and relieving pain comprises the following steps:
(1) preparing glue: cutting rubber into rubber strips of 10-20 cm, putting the rubber strips into a rubber mixing mill, rolling the rubber strips to obtain rubber sheets with the thickness of 0.6-1.5 mm, and then putting the rubber sheets into a stirrer, adding a gasoline solvent, and soaking and swelling the rubber sheets;
(2) preparing materials: adding camphor and a slow-release agent into ethanol in sequence, stirring uniformly, standing for 24-48 hours at 20-27 ℃, then adding musk, methyl salicylate, rosin and diphenhydramine hydrochloride into ethanol in sequence, stirring uniformly for dissolving, then adding a transdermal enhancer, zinc oxide, vaseline, a hot pepper fluid extract and a belladonna fluid extract in sequence, stirring uniformly to obtain a mixed feed liquid, and stirring and dissolving lanolin in diethyl ether to obtain a diethyl ether feed liquid;
(3) pulping: cutting the swelled rubber slice into rubber sections with the length less than 1cm, putting the rubber sections into a rubber beating machine, adding the mixed feed liquid and the ether feed liquid, stirring and beating the rubber, sieving the rubber by a screen to obtain rubber cement, and returning the feed liquid intercepted by the screen to beating the rubber again;
(4) homogenizing: adding a tackifier and an emulsion-increasing agent into the rubber cement, uniformly stirring, and then feeding the rubber cement into a high-speed homogenizer to perform homogenization treatment at a rotation speed of 8000-10000 r/min to obtain emulsified slurry;
(5) gluing: feeding the backing into two rolling cylinders of a glue spreader, adding emulsified slurry into the glue spreader, and coating the emulsified slurry on the backing to prepare paste;
(6) reel: the heating reeling machine controls the temperature of each oven in the reeling machine to be respectively: the temperature of the first oven is 55-65 ℃, the temperature of the second oven is 85-95 ℃, the temperature of the third oven is 65-75 ℃, and the paste reel is processed;
(7) pasting paper: pasting a piece of release paper on the plaster surface of the plaster, and coating a volatilization prevention layer on the outer side of the release paper;
(8) packaging: slicing according to the specified size, bagging and packaging to obtain the external plaster for eliminating dampness and relieving pain.
2. The external plaster for eliminating dampness and relieving pain as claimed in claim 1, wherein the mass ratio of the rubber sheet to the gasoline solvent in the step (1) is 1: 5.3-10.7, the gasoline solvent is formed by mixing No. 120 gasoline and ethanol, and the volume percentage of the No. 120 gasoline is 75-95%.
3. The external plaster for eliminating dampness and relieving pain as claimed in claim 1, wherein the volume ratio of ethanol to belladonna fluid extract in step (2) is 20-36: 1, and the volume ratio of diethyl ether to lanolin is 4-11: 1.
4. The external plaster for eliminating dampness and relieving pain as claimed in claim 1, wherein the backing is prepared by blending bamboo fibers, polypropylene fibers and polyacrylonitrile-based carbon fibers, and the mass ratio of the bamboo fibers, the polypropylene fibers and the polyacrylonitrile-based carbon fibers is 1.2-1.5: 0.6-0.9: 0.1-0.4.
5. The external plaster for eliminating dampness and relieving pain as claimed in claim 1, wherein the volatilization prevention layer in the step (7) is prepared by mixing and spraying the following components in parts by weight: 10-18 parts of water-soluble chitosan, 2-6 parts of hydroxypropyl methyl cellulose, 7-11 parts of alpha-cyclodextrin, 40-50 parts of ethanol and 100-120 parts of water, wherein the thickness of the layer is 1-5 mu m.
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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1364493A (en) * 2001-01-12 2002-08-21 杨孟君 Nano musk joint pain stopping medicine and its preparing method
CN1613463A (en) * 2003-11-07 2005-05-11 北京东方凯恩医药科技有限公司 External applied Chinese medicinal paste for treating arthralgia
CN102634307A (en) * 2012-05-03 2012-08-15 河南羚锐制药股份有限公司 Hot-melting pressure sensitive adhesive and preparation method thereof
CN104606656A (en) * 2015-01-23 2015-05-13 九寨沟天然药业集团有限责任公司 Preparation process of traditional Chinese medicine rubber electuary medicine and paste

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1364493A (en) * 2001-01-12 2002-08-21 杨孟君 Nano musk joint pain stopping medicine and its preparing method
CN1613463A (en) * 2003-11-07 2005-05-11 北京东方凯恩医药科技有限公司 External applied Chinese medicinal paste for treating arthralgia
CN102634307A (en) * 2012-05-03 2012-08-15 河南羚锐制药股份有限公司 Hot-melting pressure sensitive adhesive and preparation method thereof
CN104606656A (en) * 2015-01-23 2015-05-13 九寨沟天然药业集团有限责任公司 Preparation process of traditional Chinese medicine rubber electuary medicine and paste

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